NCT03812809

A Phase IIb Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients With T790M Mutation Positive

A Phase IIb, Open-label, Single-arm Study to Assess the Safety and Efficacy of BPI-7711 Capsule in Patients With Metastatic or Recurrent Non-small Cell Lung Cancer With EGFR Mutation and T790M Mutation Positive.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Beta Pharma Shanghai · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711 capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR mutation and T790M mutation positive.

Detailed description

This is a phase IIb, open-label, single arm study assessing the safety and efficacy of BPI-7711 (180 mg, orally, once daily) in China with a confirmed diagnosis of EGFR sensitizing mutation positive and T790M mutation+ unresectable, locally advanced or metastatic NSCLC, who have progressed on prior EGFR-TKIs treatment. The primary objective of the study is to assess the efficacy of BPI-7711 by assessment of ORR according to RECIST 1.1 by an Independent Central Review.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	BPI-7711	BPI-7711: 180mg, QD, oral

Timeline

• Start date: 2019-07-05
• Primary completion: 2022-01-24
• Completion: 2022-01-24
• First posted: 2019-01-23
• Last updated: 2022-05-19

Locations

3 sites across 1 country: China